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Service Line Lead – NAM Regulatory Development & Sciences

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Product Life Group

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Location:
United States

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Category:
Consulting

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Contract Type:
Not provided

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Salary:

200000.00 - 260000.00 USD / Year
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Job Description:

ProductLife Group is a global consulting and outsourcing partner to the life sciences industry. We support pharmaceutical and biotechnology companies across the full product lifecycle, from early development through post-marketing activities. We are seeking a Service Line Lead – NAM Regulatory Development & Sciences to hold full accountability for the performance, delivery, and growth of PLG’s Regulatory Affairs Service Line in North America.

Job Responsibility:

  • Own end-to-end performance and delivery of the Regulatory Development & Sciences Service Line
  • Drive service line KPIs including quality, timeliness, utilization, revenue, margin, and client satisfaction
  • Ensure consistent application of global standards, methodologies, SOPs, and quality requirements across all engagements
  • Act as senior escalation point for clients, balancing delivery quality, commercial objectives, and client expectations
  • Lead development and execution of global regulatory strategies across all stages of development, from pre‑IND to post‑marketing
  • Act as senior regulatory SME for complex and high‑impact programs
  • Serve as on‑demand Head / VP / Director of Regulatory Affairs for client organizations
  • Lead Health Authority interactions, including acting as Authorized Sponsor Representative when required
  • Provide strategic oversight and hands-on input into Health Authority meeting packages, special designation requests, and major regulatory submissions
  • Own financial and commercial management of the Service Line, including forecasting, budgeting, revenue planning, margin protection, and utilization
  • Partner closely with Commercial teams to support sales calls, proposals, scoping, pricing input, and bid defenses
  • Support sustainable growth of the service line through disciplined commercial decision-making
  • Lead capacity planning, resource allocation, and talent deployment in collaboration with staffing and operations
  • Lead, mentor, and develop senior regulatory professionals in a matrix consulting environment
  • Support performance management, engagement, succession planning, and retention
  • Contribute to evolution of service offerings, process improvements, and approved capability roadmaps
  • Represent the Service Line in internal governance forums and selected external or industry-facing engagements.

Requirements:

  • Bachelor’s degree in a scientific discipline (life sciences, pharmacy, biology, chemistry, or related field)
  • Advanced scientific degree (PhD, PharmD, MD, or equivalent) preferred
  • 20+ years of experience in regulatory affairs within the biotechnology and/or pharmaceutical industry
  • Demonstrated experience leading regulatory strategy and execution across early- and late-stage development through marketing authorization
  • Proven leadership experience in a consulting, professional services, or matrixed delivery environment
  • Extensive experience interacting with U.S. and ex‑U.S. Health Authorities and interpreting global regulatory frameworks
  • Deep expertise in global regulatory requirements, guidance, and legislation applicable to drug and biologic development
  • Ability to translate regulatory requirements into practical, executable development and submission strategies
  • Advanced understanding of regulatory submission strategy, Health Authority engagement, and regulatory risk management
  • Strong financial and operational acumen, including KPI management, forecasting, budgets, and utilization within consulting environments.

Additional Information:

Job Posted:
May 14, 2026

Employment Type:
Fulltime
Work Type:
Remote work
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